Procedural Sedation
Conditions
Keywords
Virtual Reality, Heart Rate, Blood Pressure
Brief summary
Children often need procedural sedation in the emergency department during painful procedures (such as reducing fractures). Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain. VR may also reduce anxiety during sedation induction by reducing providing an alternative stimulus. This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while undergoing procedural sedation. Investigators will measure heart rate, blood pressure, satisfaction (child, parent, provider), amount of sedatives used and compare between the two groups.
Interventions
DEVICEVirtual Reality
Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Children age 6 to 16 years 2. The managing physician determines need for procedural sedation 3. Parents will sign a consent form and children will sign an assent form
Exclusion criteria
1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, inability to communicate) 2. Triage category 1 (resuscitation) 3. Facial features or injury prohibiting wearing the VR goggles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate as measured by heart rate monitor | During the procedure at 1 minute intervals | The heart rate monitor will consistently display participant heart rate. Heart rate will be recorded at 1 minute intervals. The difference in heart rate from recommended mean heart rate based on age will be calculated and compared between groups. |
| Change in Blood Pressure as measured by blood pressure monitor | During the procedure at 1 minute intervals | The blood pressure monitor will display participant blood pressure. Blood pressure will be recorded at 1 minute intervals. The difference in blood pressure from recommended mean blood pressure (systolic and diastolic) based on age will be calculated and compared between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction among Guardians by global rating scale | Immediately after the procedure | Guardians will be asked On a scale of 0-10, how did the procedure go? A score of 0 represents not very well and a score of 10 represents very well. |
| Satisfaction among Emergency Staff by global rating scale | Immediately after the procedure | Emergency Staff will be asked How satisfied are you with how the procedure went? A score of 0 represents not very well and a score of 10 represents very well. |
| Emergence Phenomenon as measured by yes/no questions regarding participant experience. | Immediately after the procedure and by phone the next day | Patients will be asked whether they experienced nightmares, day-dreaming, or feeling unwell. Number of patients who experienced these negative emergence phenomenon will be tabulated and compared across groups. |
| Time difference of the procedure | Intraoperative | Time the procedure takes to complete with or without VR will be recorded to determine if there is any difference. |
| Length of stay in the Emergency Department | Intraoperative | Length of stay in the Emergency Department will also be recorded. This will be determined by the intake time noted by triage and the discharge time as witnessed by research assistant or, if unseen, by the time noted on the discharge paperwork. |
| Type and dose of medication | Intraoperative | Amount of medication and what medications were used will be gathered from the nursing notes. |
| Satisfaction among Children by global rating scale | Immediately after the procedure | Children will be asked On a scale of 0-10, how did the procedure go? A score of 0 represents not very well and a score of 10 represents very well. |
Countries
Canada
Contacts
Primary ContactRan Goldman, MD
Outcome results
None listed